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Femoston 2/10

Femoston is a hormone replacement therapy (HRT) preparation. It consists of two types of tablets; one containing the active ingredient estradiol, and the other containing two active ingredients, estradiol and dydrogesterone. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and dydrogesterone is a synthetic form of progesterone.

What is Femoston used for?

Hormone replacement therapy to relieve symptoms of the menopause.

Second-line option for preventing osteoporosis in postmenopausal women who are at high risk of fractures and cannot take other medicines licensed for preventing osteoporosis.

In December 2003, a review of the available evidence on the risks and benefits of HRT by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Committee on Safety of Medicines (CSM) in the UK, concluded that the risks of using HRT long-term to prevent osteoporosis in women aged over 50 years exceed the benefits. As a result, this medicine should not be used as a first-line option for preventing postmenopausal osteoporosis in women over 50.

However, it may be used as a second-line option for women at high risk of fractures who cannot take other medicines that are licensed for preventing osteoporosis.

Women considered to be at high risk of developing fractures following the menopause include those who have had an early menopause, those with a family history of osteoporosis, those who have had recent prolonged corticosteroid therapy (eg prednisolone), those with a small thin frame, and smokers.

You can read more about the risks and benefits of HRT and other medicines for preventing osteoporosis in the factsheets about menopause and osteoporosis linked above.

How does Femoston work?

Femoston is a hormone replacement therapy (HRT) preparation. It consists of two types of tablets; one containing the active ingredient estradiol (previously spelt oestradiol in the UK), and the other containing two active ingredients, estradiol and dydrogesterone. These are forms of the main female sex hormones, oestrogen and progesterone. Estradiol is a naturally occuring form of oestrogen and dydrogesterone is a synthetic form of progesterone.

Womens ovaries gradually produce less and less oestrogen in the period up to the menopause, and oestrogen blood levels decline as a result. The declining levels of oestrogen can cause distressing symptoms, such as irregular periods, hot flushes, night sweats, mood swings and vaginal dryness or itching.

Oestrogen (in this case in the form of estradiol) can be given as a supplement to replace the falling levels in the body and help reduce these distressing symptoms of the menopause. This is known as hormone replacement therapy (HRT). HRT is usually only required for short-term relief from menopausal symptoms and its use should be reviewed at least once a year with your doctor.

A progestogen (in this case in the form of dydrogesterone) is needed as part of HRT for women who have not had a hysterectomy. This is because in women with an intact womb, oestrogen stimulates the growth of the womb lining (endometrium), which can lead to endometrial cancer if the growth is unopposed. A progestogen is given to oppose oestrogen's effect on the womb lining and reduce the risk of endometrial cancer, though it does not eliminate this risk entirely. This is known as combined HRT.

Femoston is a sequential form of combined HRT. This means that oestrogen is taken on a continuous basis and the progestogen is added for the last two weeks of each month. The tablets taken in the first two weeks of each Femoston cycle contain only estradiol, while the tablets taken in the second two weeks of each cycle contain both estradiol and dydrogesterone. This type of HRT is more suitable for women who are still having irregular periods, because it usually results in a monthly bleed towards the end of taking the dydrogesterone.

HRT is also sometimes used to prevent osteoporosis in postmenopausal women. The declining level of oestrogen at menopause can affect the bones, causing them to become thinner and more prone to breaking. Oestrogen supplements help prevent bone loss and fractures that may occur in women in the years after menopause.

How do I take Femoston tablets?

Femoston tablets come in a 28 day calendar pack. You should take one tablet every day in the order marked on the pack, starting with the tablets from the part marked with arrow 1, followed by the tablets from the part marked with arrow 2. You should then start the next pack without a break. Your need for continued HRT should be reviewed with your doctor at least once a year.

The tablets should be swallowed whole with a drink. They can be taken either with or without food.

Your tablet should be taken at around the same time each day; this will help you remember to take it.

If you forget to take a dose at your usual time and it is less than 12 hours late when you remember, you should take the missed dose. If it is more than 12 hours late you should just leave out the forgotten dose and take your next dose as usual at your usual time. Don't take a double dose to make up for a missed dose.

Femoston should be used with caution by

Women with a risk of developing cancers that are stimulated by oestrogen, for example women whose mother or sister has had breast cancer.

Women with a history of benign breast lumps (fibrocystic breast disease).

Women with fibroids in the womb.

Women with a history of endometriosis.

Women with a history of overgrowth of the lining of the womb (endometrial hyperplasia).

Women with a personal or family history of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).

Women with raised levels of fats such as cholesterol or triglycerides in their blood.

Women with a history of gallbladder disease.

Women with a long-term condition called systemic lupus erythematosus (SLE).

Women who suffer from migraines or severe headaches.

Women with epilepsy.

Women with a history of asthma.

Women with a history of depression.

Women with a history of irregular brown patches appearing on the skin, usually of the face, during pregnancy or previous use of hormone preparations such as contraceptive pills (chloasma). Women with a tendency to this condition should minimise their exposure to the sun or UV light while taking HRT.

Femoston should not be used by

Women with known, suspected, or a past history of breast cancer.

Women with known or suspected cancer in which growth of the cancer is stimulated by oestrogen, eg cancer of the lining of the womb (endometrial cancer).

Women with untreated overgrowth of the lining of the womb (endometrial hyperplasia).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used by women who are pregnant or breastfeeding. You should stop taking this medicine and consult your doctor immediately if you think you could be pregnant during treatment.

A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. HRT does not provide contraception for women who fall within this group. If you could get pregnant while taking this HRT, you should use a non-hormonal method of contraception (eg condoms or contraceptive foam). Seek further medical advice from your doctor.

Possible side effects of Femoston

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. See also the important information section above. Just because a side effect is stated here, it does not mean that all women using this medicine will experience that or any side effect.

Steepening of corneal curvature, which may make contact lenses uncomfortable.

Skin reactions such as rash and itching.

Irregular brown patches on the skin, usually of the face (chloasma).

Disturbance in liver function and jaundice.

Gallbladder disease.

Inflammation of the pancreas (pancreatitis).

Blood clots in the blood vessels.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

If you think you have experienced a side effect from a medicine or vaccine you should check the patient information leaflet. This lists the known side effects and what to do if you get them. You can also get advice from your doctor, nurse or pharmacist. If they think it's necessary they'll report it for you.

You can also report side effects yourself using the yellow card website: www.mhra.gov.uk/yellowcard.

How can Femoston affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

The following medicines may potentially reduce the blood level and effect of this medicine, which could cause irregular menstrual bleeding or your symptoms to come back:

aprepitant

bosentan

barbiturates

carbamazepine

cobicistat

crizotinib

dabrafenib

efavirenz

eslicarbazepine

fosaprepitant

fosphenytoin

modafinil

nevirapine

oxcarbazepine

phenobarbital

phenytoin

primidone

rifabutin

rifampicin

ritonavir

rufinamide

telaprevir

the herbal remedy St John's wort (Hypericum perforatum)

topiramate

vemurafenib.

Some women with diabetes may need small adjustments in their dose of insulin or antidiabetic tablets while taking this medicine. You should monitor your blood sugar and seek advice from your doctor or pharmacist if your blood sugar control seems to be altered after starting this medicine.

This medicine may oppose the effect of medicines used to lower high blood pressure. Your blood pressure will usually be checked periodically while you are taking HRT, but this is particularly important if you are also taking medicines for high blood pressure.

This medicine may also oppose the fluid-losing effect of diuretic medicines.

This medicine may decrease the amount of the antiepileptic medicine lamotrigine in the blood. As this could increase the risk of seizures coming back or getting worse, the medicine may not be recommended for women who take lamotrigine on its own for epilepsy.

This medicine may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects: